Major Depressive Disorder and Persistent Depressive Disorder
Conditions
Sponsors
Brydun Andrey
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: At the initiation of the screening period -Japanese male or female aged between 12 and 17 years at the initiation of the screening period (Visit 1). -Participants/parents who provided applicable written consent and written informed assent. -Outpatient participants. -Participants with a diagnosis of major depressive disorder or persistent depressive disorder based on the DSM-5 diagnostic criteria. -Educational level and degree of understanding so that the participants and parents could communicate intelligibly with the investigator and study coordinator; normal intelligence based on the judgment of the investigator.
Exclusion criteria
Exclusion criteria: Medical Conditions: -Participants who have received any prior treatment with venlafaxine or desvenlafaxine. -Participants with known hypersensitivity to venlafaxine or desvenlafaxine. -Participants with a history or the presence of clinically significant cardiac, hepatic, renal, respiratory, endocrinological, neurological, or hematological disease. -Participants with a history or complication of ocular tension increased or acute narrow-angle glaucoma. -Participants with a history or the presence of other medical disease that might compromise the study. -Participants with a history of seizure other than a single childhood febrile seizure. -Participants with a history or presence of major depression with psychotic features. -Participants with a history or presence of anorexia nervosa or bulimia nervosa. 14. Participants with a presence of conduct disorder. -Participants with a presence of conduct disorder. -Female participants who are pregnant or breast-feeding, or who are suspected to be pregnant, or planning to become pregnant. -Females who are sexually active and do not use medically acceptable forms of contraception. -Participants with a history of drug or alcohol dependence or abuse based on the DSM-5 criteria within 1 year. -Participants who have any clinically significant abnormalities on the pre-study physical examination, ECG, or laboratory tests. -Participants with a history or complication of gastrointestinal disorders or a history of surgery that interfere with drug absorption/ excretion. -Participants with a history of malignant tumor within 2 years, except for basal cell or squamous cell skin cancer. -Participants who plan to receive prohibited concomitant drugs/therapies. -Participation in any other clinical trials within 3 months before the initiation of the screening period or wish to participate in other clinical study during this study. -Participants who have any serious acute/chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk of study participation, affect the interpretation of the study results, or, in the investigators judgment, make the participant inappropriate for the study. At baseline (at the initiation of the double-blind period) -Participants who have used any investigational drug, antipsychotic drug, electroconvulsive therapy (ECT), transcranial magnetic stimulation, systematic psychotherapy (including cognitive behavioral therapy) or light therapy within 30 days before the initiation of the double-blind period. -Participants who have used fluoxetine within 35 days before the initiation of the double-blind period. -Participants who have used any MAO inhibitor or any triptan drugs within 14 days before the initiation of the double-blind period. -Participants who have used St. Johns wort or Chinese herb medicine products within 14 days before the initiation of thedouble-blind period. -Participants who have used any other antidepressant, anxiolytic, sedative-hypnotic drug or any other psychotropic drug or substancewithin 14 days before the initiation of the double-blind period. -Participants who have used any non-psychopharmacologic drug with psychotropic effects within 7 days before the initiation of the double-blind period, unless a stable dose of the drug had been maintained for at least 1 month before the initiation of the doubleblind treatment period. -Potential need for the continuation or initiation of other treatments for depression, including cognitive-beha
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Population-based average treatment effect on change from baseline CDRS-R score for venlafaxine | — |
Contacts
Public ContactClinical trial contact
ICON Clinical Research GK
Outcome results
None listed